78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details
臨床試験数 : 494 / 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-000929-42-BG (EUCTR) | 07/01/2022 | 20/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 2 | EUCTR2020-000929-42-DK (EUCTR) | 05/08/2021 | 12/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 3 | EUCTR2020-000929-42-DE (EUCTR) | 09/06/2021 | 14/10/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Japan;New Zealand;Germany;Bulgaria;Georgia;Romania;Poland;Canada;Armenia;United Kingdom;Turkey;Netherlands;Denmark;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Serbia | ||
| 4 | EUCTR2020-000929-42-ES (EUCTR) | 21/04/2021 | 01/02/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 5 | EUCTR2020-000929-42-SK (EUCTR) | 12/04/2021 | 24/11/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 6 | EUCTR2020-000929-42-GR (EUCTR) | 23/03/2021 | 04/03/2021 | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Belarus;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 7 | NCT04513171 (ClinicalTrials.gov) | December 26, 2018 | 7/8/2020 | Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children | A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency. | Growth Hormone Deficiency | Drug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: Norditropin | Xiamen Amoytop Biotech Co., Ltd. | Tongji Hospital | Recruiting | 3 Years | 11 Years | All | 400 | Phase 2/Phase 3 | China |
| 8 | EUCTR2017-003410-20-IT (EUCTR) | 30/10/2018 | 11/10/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany | ||
| 9 | EUCTR2017-003410-20-PL (EUCTR) | 23/10/2018 | 08/11/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Belarus;United States;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Georgia;Bulgaria;Germany | ||
| 10 | ChiCTR1800017144 | 2018-07-25 | 2018-07-13 | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | Growth hormone deficiency | Two groups:low dose versus high dose of Pegylated Somatropin; | The Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 3 | 14 | Both | Two groups:900; | China‘ | |
| 11 | EUCTR2017-003410-20-GR (EUCTR) | 04/06/2018 | 19/04/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 12 | EUCTR2017-003410-20-BG (EUCTR) | 20/04/2018 | 09/01/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth HormoneDeficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 13 | EUCTR2016-001145-11-DE (EUCTR) | 12/02/2018 | 14/12/2016 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine | ||
| 14 | EUCTR2016-001145-11-IT (EUCTR) | 07/04/2017 | 10/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH CT-301 (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: Sterile Water for Injection | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 15 | NCT03104010 (ClinicalTrials.gov) | April 2017 | 28/3/2017 | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: Somatropin Injection | GeneScience Pharmaceuticals Co., Ltd. | Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China Hospital | Recruiting | 18 Years | 60 Years | All | 180 | Phase 2 | China |
| 16 | EUCTR2016-001145-11-PL (EUCTR) | 31/03/2017 | 17/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 17 | EUCTR2016-001145-11-GR (EUCTR) | 28/03/2017 | 02/02/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 18 | NCT03290235 (ClinicalTrials.gov) | March 1, 2017 | 19/9/2017 | Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | Growth Retardation | Drug: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 42 Months | 15 Years | All | 1500 | Phase 4 | China |
| 19 | NCT03249480 (ClinicalTrials.gov) | January 2015 | 24/7/2017 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Beijing Children's Hospital;Tianjin Medical University General Hospital;Peking University Third Hospital;China-Japan Friendship Hospital;Dalian Children's Hospital;Xi'an Children's Hospital;Wuhan Children's Hospital;Fuzhou Children s Hospital;Anhui Provincial Children's Hospital;Hunan Children's Hospital;Shenzhen Children's Hospital;Children's Hospital of Hebei Province;Second Affiliated Hospital of Xi'an Jiaotong University;Children's Hospital of Zhengzhou;Children's Hospital Of Soochow University;Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region;The First Affiliated Hospital of Kunming Medical College;Kunming Children's Hospital;The First People's Hospital of Yunnan;Xuzhou Children's Hopspital;Henan Provincal People's Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;First Affiliated Hospital of Harbin Medical University;The Second Hospital of Hebei Medical University;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;Union Hospital of Tongji Medical College of HUST;Wuxi Children's Hospital;The Second Affiliated Hospital of Kunming Medical University;Nanjing Children's Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 20 | NCT02976675 (ClinicalTrials.gov) | January 2015 | 24/11/2016 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Suzhou Municipal Hospital;General Hospital of Ningxia Medical University;The First Affiliated Hospital of Henan University of Science and Technology;Maternal and Child Health Hospital of Hubei Province;Nantong University | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China |
| 21 | NCT02380235 (ClinicalTrials.gov) | December 2014 | 2/3/2015 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I) | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China | |
| 22 | NCT02314676 (ClinicalTrials.gov) | November 2014 | 27/11/2014 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Dwarfism, Pituitary | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 3 Years | N/A | Both | 900 | Phase 4 | China | |
| 23 | NCT02908958 (ClinicalTrials.gov) | November 2014 | 19/9/2016 | Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency | Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | The Children's Hospital of Zhejiang University School of Medicine;The Second Hospital of Anhui Medical University;Guangzhou Women and Children's Medical Center;First People's Hospital of Hangzhou;Qilu Hospital of Shandong University;Zhejiang Provincial People’s Hospital;Zhejiang Provincial Hospital of TCM;Central South University;Southwest Hospital, China;First Affiliated Hospital of Guangxi Medical University;Shanghai Children's Medical Center;Second Affiliated Hospital of Wenzhou Medical University;The First Affiliated Hospital of Xiamen University;Third Affiliated Hospital, Sun Yat-Sen University;Xiangya Hospital of Central South University;Shaoxing Second Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 24 | EUCTR2012-002787-27-BG (EUCTR) | 11/09/2013 | 03/06/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany | ||
| 25 | EUCTR2012-002787-27-SI (EUCTR) | 10/07/2013 | 10/07/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 26 | EUCTR2012-002787-27-DE (EUCTR) | 17/06/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 27 | EUCTR2012-002787-27-CZ (EUCTR) | 10/05/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 28 | EUCTR2012-002787-27-GR (EUCTR) | 04/03/2013 | 15/02/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 29 | EUCTR2012-002787-27-HU (EUCTR) | 11/02/2013 | 11/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 30 | NCT01804413 (ClinicalTrials.gov) | March 2011 | 18/2/2013 | Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency | Effects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot Study | Adults Growth Hormone Deficiency. | Drug: Pegvisomant;Drug: Regular insulin | Oregon Health and Science University | Aarhus University Hospital | Recruiting | 21 Years | 55 Years | Both | 10 | N/A | United States |
| 31 | NCT01613573 (ClinicalTrials.gov) | March 2010 | 1/6/2012 | Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children | A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children | Growth Hormone Deficiency | Drug: somatropin AQ;Drug: pegylated somatropin | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology | Completed | 4 Years | 10 Years | Male | 12 | Phase 1 | NULL |
| 32 | EUCTR2008-008240-25-ES (EUCTR) | 04/11/2009 | 10/08/2009 | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Déficit de hormona de crecimientogrowth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Slovenia;Belgium;Spain;Denmark;United Kingdom | ||
| 33 | EUCTR2008-008240-25-DK (EUCTR) | 12/10/2009 | 17/08/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Slovenia;Denmark;France;Spain | |||
| 34 | EUCTR2008-008240-25-GB (EUCTR) | 01/10/2009 | 18/06/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain | |||
| 35 | EUCTR2008-008240-25-FR (EUCTR) | 02/09/2009 | 10/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | ||
| 36 | NCT00936403 (ClinicalTrials.gov) | August 2009 | 9/7/2009 | A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone | A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: NNC126-0083;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 6 Years | 12 Years | All | 31 | Phase 2 | Belgium;Czech Republic;Denmark;France;Israel;Macedonia, The Former Yugoslav Republic of;Slovenia;Spain;Turkey;United Kingdom |
| 37 | EUCTR2008-008240-25-BE (EUCTR) | 10/06/2009 | 24/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | |||
| 38 | EUCTR2008-008240-25-SI (EUCTR) | 25/05/2009 | 06/05/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain | |||
| 39 | EUCTR2007-001746-40-HU (EUCTR) | 25/08/2008 | 02/04/2007 | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: ARX201 Other descriptive name: Pegylated recombinant human growth hormone | Ambrx, Inc., USA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Hungary | ||
| 40 | EUCTR2008-001061-29-DK (EUCTR) | 17/06/2008 | 29/04/2008 | A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) | A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) | Growth hormone deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: NN8630 Product Code: NNC 126-0083 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Denmark | |||
| 41 | EUCTR2005-005587-82-GR (EUCTR) | 28/11/2007 | 28/06/2007 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 42 | EUCTR2005-005587-82-PL (EUCTR) | 07/07/2007 | 31/05/2007 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | Czech Republic;Greece;Belgium;Poland;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 43 | NCT01495468 (ClinicalTrials.gov) | March 2007 | 16/12/2011 | Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical Trial | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Tongji Hospital;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University;First Hospital of Jilin University | Completed | 8 Years | 15 Years | All | 343 | Phase 3 | China |
| 44 | EUCTR2005-005587-82-CZ (EUCTR) | 15/02/2007 | 25/10/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 45 | EUCTR2005-005587-82-NL (EUCTR) | 08/08/2006 | 12/05/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer | Pfizer | Not Recruiting | Female: yes Male: yes | 136 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 46 | EUCTR2005-005593-79-BE (EUCTR) | 31/07/2006 | 11/05/2006 | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer N.V./S.A. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Spain;Belgium;Germany;United Kingdom | |||
| 47 | EUCTR2005-005587-82-BE (EUCTR) | 03/07/2006 | 22/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer NV/SA | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Greece;Poland;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 48 | EUCTR2005-005587-82-DE (EUCTR) | 21/06/2006 | 06/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 136 | Czech Republic;Greece;Poland;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 49 | EUCTR2005-005587-82-SE (EUCTR) | 12/06/2006 | 02/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer AB;Pfizer Ltd | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | ||||
| 50 | EUCTR2005-005593-79-DE (EUCTR) | 09/06/2006 | 03/04/2006 | A Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | A Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Germany;Spain | |||
| 51 | EUCTR2005-005593-79-GB (EUCTR) | 02/06/2006 | 21/03/2006 | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 32 | Germany;United Kingdom;Spain | |||
| 52 | EUCTR2005-005593-79-ES (EUCTR) | 31/05/2006 | 04/04/2006 | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Code: PHA-794428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Code: PHA-794428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer SA | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Belgium;Spain;Germany;United Kingdom | ||
| 53 | EUCTR2005-005587-82-GB (EUCTR) | 17/05/2006 | 20/04/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Code: PHA-794,428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Code: PHA-794,428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 136 | Sweden;Poland;Greece;Italy;Denmark;Netherlands;United Kingdom;Czech Republic | |||
| 54 | NCT01342146 (ClinicalTrials.gov) | May 2006 | 21/4/2011 | Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children | Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study | Growth Hormone Deficiency | Drug: pegylated Somatropin;Drug: Jintropin AQ | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University | Completed | N/A | N/A | All | 101 | Phase 2 | NULL |
| 55 | EUCTR2005-005587-82-DK (EUCTR) | 26/04/2006 | 15/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 136 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 56 | NCT00468624 (ClinicalTrials.gov) | December 2004 | 2/5/2007 | Effect of Pegvisomant on GH/IGF-I Relationship in GHD | A Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD) | Severe Adult Growth Hormone Deficiency | Drug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limb | Christie Hospital NHS Foundation Trust | NULL | Terminated | 18 Years | 70 Years | Both | N/A | United Kingdom | |
| 57 | EUCTR2016-001145-11-BG (EUCTR) | 11/01/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | |||
| 58 | EUCTR2012-002787-27-FR (EUCTR) | 23/09/2015 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany |